Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant.

Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant.

Does the patient have a clinically significant, uncontrolled autoimmune disease requiring active medical management (immunosuppressive therapy or chemotherapy), which, in the judgment of the local Principal Investigator, indicates that the patient could not tolerate transplantation?

1;2;1;2

Yes;No;Yes;No

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-11 10:33:42.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCAIMM

C18027

Comment text

CmmntTxt

Provide any additional information that pertains to the question.

Provide any additional information that pertains to the question.

Comments

Alphanumeric

Adult;Pediatric

Proposed

3.00

2013-07-16 14:01:43.01

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

4000

Free-Form Entry

DeBaun Forms

C58733

Oxygen saturation measurement date

OxygenSaturationMeasrDate

Date on which the measurement of the subject/participant's oxygen saturation level was obtained.

Date on which the measurement of the subject/participant's oxygen saturation level was obtained.

Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second.

Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second.

Does the patient have an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) >= 2.7m/sec?

1;2;1;2

Yes;No;Yes;No

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-06 10:39:20.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCTRJV

C58781

Abstinence contraception 2 form agree practice indicate code

AbstncCntracep2FrmAgrPrxIndCod

Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence.

Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence.

Does the patient agree either (1) to practice 2 effective methods of contraception at the same time, or (2) to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-transplant?

Did the donor give consent to provide blood samples for optional study-specific research?

1;2;1;2

Yes;No;Yes;No

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-11 13:43:40.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCPSMPL

C58714

History acute chest syndrome despite care two year before enrollment indicate code

HxACSDsptCr2YrBfrEnrIndCode

Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures.

Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures.

Does the patient have a history of two or more episodes of acute chest syndrome (ACS) in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea)?

1;2;3

Yes;No;Unavailable

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-06 09:48:32.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCACS

C58746

Alanine aminotransferase sample date

ALTSampleDate

Date on which the alanine aminotransferase (ALT) sample was collected.

Date on which the alanine aminotransferase (ALT) sample was collected.

Date ALT sample obtained

Date or Date & Time

Adult;Pediatric

Proposed

1.00

2018-12-10 09:11:55.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCALTDT

C58762

Human leukocyte antigen typing donor confirmatory date

HLATypConfirmatoryDate

Date on which confirmatory typing of the donor's human leukocyte antigen (HLA) status was performed.

Date on which confirmatory typing of the donor's human leukocyte antigen (HLA) status was performed.

Date confirmatory typing completed

Date or Date & Time

Adult;Pediatric

Proposed

1.00

2018-12-10 13:03:39.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCHLADT

C58725

Tricuspid valve regurgitant jet velocity echocardiograph measurement

TRJVEchcrdgrphMeasr

Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph.

Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph.

Does the patient (even if surgically sterilized) agree to practice effective barrier contraception, or agree to practice true abstinence from the time of signing informed consent through 12 months post-transplant?

Code indicating whether the subject/participant had an uncontrolled bacterial, viral, or fungal infection in the 6 weeks prior to his or her enrollment in the study.

Code indicating whether the subject/participant had an uncontrolled bacterial, viral, or fungal infection in the 6 weeks prior to his or her enrollment in the study.

Has the patient experienced an uncontrolled bacterial, viral, or fungal infection in the 6 weeks before enrollment (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)?

1;2;1;2

Yes;No;Yes;No

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-10 16:05:10.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCINFEC

C58727

Sickle cell disease type code

SickleCellDiseaseTypeCode

Code for the type of sickle cell disease that the subject/participant has.

Code for the type of sickle cell disease that the subject/participant has.

HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1.

Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images.

Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images.

Has the patient experienced a focal neurological event resulting in abnormalities on T2-weighted or FLAIR images using an MRI scan, indicative of an acute infarct, with no other reasonable medical explanation?

1;2;3

Yes;No;Unavailable

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-11-21 10:11:57.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCNEUEV

C58738

Creatinine clearance most recent measurement

CreatininClearMostRecntMeasr

Measurement of creatinine clearance from the most recent sample taken from the subject/participant

Measurement of creatinine clearance from the most recent sample taken from the subject/participant

Creatinine clearance most recent value (mL/min/1.73m^2)

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-06 12:09:07.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

0

999.99

milliliter per minute per 1.73 square meters

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCCRCL

C58717

History pain crisis sickle related complication over two per year prior enrollment indicate code

HxPnCrScReCoOv2PrYrPriEnrInCod

Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication.

Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication.

Does the patient have a history of three or more severe vaso-occlusive pain crises per year in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea); painful episodes related to priapism, osteonecrosis or any sickle-related complication?

1;2;3

Yes;No;Unavailable

Numeric Values

Adult;Pediatric

Proposed

1.00

2018-12-06 10:06:28.0

Haplo Sickle Cell Enrollment Form: Segment A

Protocol Experience

Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN

1507A Release 5.10

1507A (ENR)

HSCVOC

C58750

Red blood cell transfusion 8 times year 20 times ever indicate code

RBCTrsfn8xYr20xEvrIndCode

Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime.

Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime.

Is the patient currently receiving >= 8 packed red blood cell transfusions per year for >= 1 year or has the patient received >= 20 packed red blood cell transfusions (lifetime cumulative)?

HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1.